MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO., LTD. PROBASICS; HALF LENGTH BED RAILS

Model Number PB7035

Device Problem No Apparent Adverse Event (3189)

Patient Problem Death (1802)

Event Date 06/03/2019

Event Type  Death  

Event Description

The end-user was sleeping in a hospital bed with probasics bed rails when he became trapped between the bedrail and hospital bed and died from positional asphyxia.

• Brand Name: PROBASICS
• Type of Device: HALF LENGTH BED RAILS
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO., LTD.; no.96, zhaoyi rd.; dongsheng town; zhongshan city guangdong, ; CH
• MDR Report Key: 10384044
• MDR Text Key: 202178963
• Report Number: 3012316249-2020-00024
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PB7035
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2020
• Distributor Facility Aware Date: 08/05/2020
• Date Report to Manufacturer: 08/10/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death